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Senior Regulatory Affairs Specialist - Bothell, United States - React Health
Description
POSITION:
Senior Regulatory Affairs Specialist
LOCATION:
HybridReact Health is a fast paced, growth oriented, manufacturer and distributor of medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers.
React Health sells and supports its product and services in the acute-care, non-acute and home medical equipment markets.React Health has built a model that combines manufacturing and distribution of products and services to meet the challenges of the undiagnosed as well as those needing therapies after diagnosis in the sleep and respiratory population.
GENERAL SUMMARYThe Senior Regulatory Affairs (RA) Specialist assesses product changes for reportability to appropriate regulatory agencies.Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
QUALIFICATIONSBachelors degree in engineering or life science discipline, or equivalent experienceMinimum 7 years of RA experience in the medical device industryStrong understanding of ISO 13485 and FDA 21 CFR Part 820 requirementsStrong understanding of statistical techniquesRegulatory Affairs Certification (RAC) highly preferredExcellent communication and documentation skillsStrong organization and attention to detail skillsPreferred Education Masters degree in engineering or life science discipline, or equivalent experiencePreferred Experience Excellent attention to detail and project management skills.
Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people.Physical Demands Requires normal visual acuity and hearing.
Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.
Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.Additional skills may be required to perform additional task(s) specific to work location, department or line of business.
Working Conditions Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment.
DUTIES AND ESSENTIAL FUNCTIONSEach Employee consistently demonstrates the following essential functions:
Prepare and maintain regulatory submissions, maintain 510k product registrations.
Approve design/manufacturing changes. Analyze product changes for impact to current regulatory filingsMaintain current standards list. Identify and lead projects to comply with latest standards (FDA expectation)
Regulatory Intelligence:
Monitor regulatory environment (FDA), Provide regulatory environment update in Management ReviewsPrimary point of contact for FDA interaction (questions/responses). Participate in FDA inspection as needed.
Recall administrationParticipate in/lead internal auditsStay current on international regulatory requirements and lead appropriately regulatory approvals.
Lead CE mark requirement definition/implementationSupport maintaining a cGMP compliant Quality Management System to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, (MDD 93/42/EEC, MDR 2017/745,) and ISO 13485 regulatory requirements.
Develop relevant regulatory procedures and work instructions as necessary.Lead audit readiness initiative. Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance.
Attends and participates in departmental meetings.
Attends seminars and training sessions necessary to maintain appropriate level of professional competenceEnsures all department compliance guidelines are metAttends all meetings, in-services training, or continuing education as delegated by the supervisorProvides customer focused interactionsPerforms all duties necessary for the department as per department policies and proceduresPerforms other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the departmentReasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care.
React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace.We are an Equal-Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
ABOUT THE ORGANIZATION React Health is committed to providing innovative sleep, sanitation and consumer devices.Our goal is to provide the highest quality products that comply with all regulatory requirements and meet or exceed the market expectations and needs of our customers, employees and investors.
BONUS :
P otential annual bonus based on performance#J-18808-Ljbffr
